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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules calculation approximating the 90th percentile using the lognormal distribution. The GM and STV values are initially derived based on an initial survey data set that consists of a minimum total of 20 samples for untreated surface water sources taken over at least 2 years and no more than 4 years and 4 samples for untreated ground water sources taken during the growing season or over a period of 1
year.
Following the initial survey, covered farms revise the GM and STV values based on annual survey data, which consists of at least 5 new samples per year for untreated surface water sources and at least one new sample per year for untreated ground water sources. The new samples are then combined with
the most recent data from within the previous 4 years, to make up a rolling dataset of 20 samples for untreated surface water and 4 samples for untreated ground water. The GM and STV values are recalculated using this updated data set to update the microbial water quality profile for certain preharvest agricultural water for covered produce, other than sprouts 112.46b. When testing untreated surface water or untreated ground water sources used during growing activities using a direct water application method, the initial and annual survey samples must be representative of covered farms use of the water and must be collected as close in time as practicable to, but prior to, harvest.

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In the produce safety final rule, FDA
committed to implementing the final rule though a broad, collaborative effort to foster awareness and compliance with guidance, education, and technical assistance, coupled with accountability for compliance 80 FR 74354 at 74519.
This proposal continues that commitment.
Table 2 lists the key FSMA produce safety regulation documents published in the Federal Register. The complete set of Federal Register documents associated with the FSMA produce safety regulation, including supporting materials, are available in the docket folder at https www.regulations.gov/
docket?D=FDA-2011-N-0921.

TABLE 2LIST OF KEY FEDERAL REGISTER PRODUCE SAFETY REGULATION DOCUMENTS
Description
Publication
Notice of proposed rulemaking 2013 proposed produce safety rule
Notice of correction for the 2013 proposed produce safety rule
Supplemental notice of proposed rulemaking supplemental notice
Final rule 2015 produce safety final rule or final rule
Technical amendment to the 2015 produce safety final rule
FSMA: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules; Final rule.
Extension of Compliance Dates for Subpart E; Notice of proposed rulemaking
Extension of Compliance Dates for Subpart E; Final rule subpart E compliance date extension or compliance date extension.

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C. Stakeholder Concerns Regarding Certain Pre-Harvest Agricultural Water Requirements In November 2015, FDA began to conduct outreach to educate stakeholders about the new requirements of the produce safety rule and share the Agencys implementation plans, in keeping with our commitment to a broad, collaborative effort to foster awareness about, and compliance with, the rule.
Upon release of the produce safety final rule in November 2015, FDA
conducted a webinar with nearly 400
participants, in which FDA subject matter experts discussed the significant provisions of the rule and answered questions. Beginning in December 2015, subject matter experts discussed the produce safety regulation at a series of public meetings held in the United States and abroad. This included four regional meetings in Oregon December 1, 2015; Vermont December 15, 2015;
Florida January 27, 2016; and North Carolina February 4, 2016, that were attended by growers and other interested stakeholders and sponsored by State regulatory partners. Also in December 2015, FDA officials and subject matter experts discussed the
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requirements of the produce safety rule and other foundational FSMA rules at a public meeting convened by the European Commission. Later that month, FDA subject matter experts briefed U.S.-based embassy personnel on the contents of the FSMA rules, including the produce safety rule.
In 2016 and 2017, FDA continued outreach and education efforts to inform stakeholders, including industry, consumers, academia, and regulatory partners, about the produce safety rule requirements and FDAs implementation plans through speaking engagements and participation in conferences convened by stakeholders representing a broad range of interests.
FDA subject matter experts also participated in educational farm visits with State partners to observe the range of growing conditions and practices across the United States e.g., Alaska, Arizona, California, Colorado, Georgia, Maine, Maryland, Nevada, New Mexico, Oregon, Texas, Vermont, Washington, and Wisconsin. Through these farm visits, together with speaking engagements, conferences, coalition meetings, and questions about the rule submitted to the FSMA Technical Assistance Network, FDA gained an understanding that numerous industry
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3504, January 16, 2013.
17155, March 20, 2013.
58434, September 29, 2014.
74354, November 27, 2015.
26466, May 3, 2016.
57784, August 24, 2016.

82 FR 42963, September 13, 2017.
84 FR 9706, March 18, 2019.

stakeholders found certain provisions of subpart E to be the difficult to understand, translate, and implement in their operationsin particular, the preharvest microbial quality criteria and testing requirements that required farms to establish a Microbial Water Quality Profile MWQP for each water source used for non-sprout covered produce.
For example, FDA repeatedly heard from covered farms and produce industry associations that the preharvest agricultural water microbial quality criteria 112.44b and testing requirements 112.46b are too complicated to understand, and that questions remain about how to implement them in a practical manner.
We also heard consistent feedback from covered farms and produce industry associations that these requirements do not sufficiently allow for a variety of water uses and availabilities.
Specifically, this feedback centered on the following issues:
A number of these stakeholders stated that they have large numbers of water sourcesin some cases, dozens of surface water sources, or upwards of one hundred ground water sourcesfor which they would have to establish individual MWQPs under the final rule.

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